Clinical Trial to Assess Safety of SI-6603 in Patients Wi... | NCT01282606

Studies
Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation

NCT01282606

Sponsor

Seikagaku Corporation

Status

Completed

Last Update Posted

Mar 23, 2023Actual

Enrollment

18Actual

Phase

Phase 2

Conditions

Lumbar Vertebra Hernia

Interventions

SI-6603

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Aug 2012Actual

Completion Date

Not provided

First Submitted Date

Jan 24, 2011

First Submission Date that Met QC Criteria

Jan 24, 2011

First Posted Date

Jan 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jul 12, 2012

Certification/Extension First Submitted that Passed QC Review

Jul 25, 2012

Certification/Extension First Posted Date

Aug 2, 2012Estimated

Last Update Submitted Date

Mar 21, 2023

Last Update Posted Date

Mar 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Drug I: SI-6603 (Low)	Experimental	Drug: SI-6603
Drug II: SI-6603 (Middle)	Experimental	Drug: SI-6603
Drug III: SI-6603 (High)	Experimental	Drug: SI-6603

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SI-6603	Drug	SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.	Drug I: SI-6603 (Low) Drug II: SI-6603 (Middle) Drug III: SI-6603 (High)

Measure	Description	Time Frame
Adverse events		52 weeks

Measure	Description	Time Frame
The leg pain		At each assessment time point

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with lumbar disc herniation (L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root.
Patients assessed as positive in the SLR test.
Patients with sciatica in either lower leg.
Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block.

Exclusion Criteria:

Patients who have 2 or more lumbar disc herniations as assessed by MRI.
Patients with "extrusion-type" or "sequestration-type" herniation in whom a rupture into the posterior longitudinal ligament is identified by MRI.
Patients who have received nerve block within 3 weeks before screening.
Patients who have undergone lumbar operation, chemonucleolysis, or percutaneous nucleotomy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SKK		Encinitas	California	92024	United States

Condition Browse Module

MeSH Terms

ID	Term
D006547	Hernia

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided